Alternate the hip on which the patch is worn each day to reduce potential irritation. Gently fold back the other half and slowly peel off the remaining protective liner.
Press the entire patch firmly into place and hold for about 30 seconds. This ensures adhesion of the patch to the skin. Go over the edges with your fingers to make sure that it's secure. NOTE: Wash your hands immediately after applying the patch.
Patches should not be reapplied with bandages, tape, or other household adhesives. Also, do not use hair dryers, heating pads, electric blankets, or other heat sources directly on the patch. If you have to replace a patch that has fallen off, the total wear time for the first and second patch should not be more than a total of 9 hours in 1 day.
Do not reapply the same patch that fell off. Peel the patch off slowly, then fold the used patch in half so that it sticks to itself. Flush the used patch down the toilet or, if you have a septic tank, dispose of it in a lidded trash receptacle right away.
Remove any adhesive residue from the skin by gently rubbing the area with oil or lotion. Remove patches from their protective pouches, peel off the liners, and fold the sticky sides together.
Then flush the patches down the toilet or throw away in a lidded trash receptacle right away. Wash your hands after you handle the patch. Proper disposal is important since unneeded or expired patches still contain medication that could be harmful to small children or pets if touched or consumed. Offer valid for up to a total of 12 prescriptions of 30 patches. Offer limited to one use per month. Learning may or may not be impaired. Drug treatment may not be indicated for all patients with this syndrome.
Appropriate educational placement is essential and psychosocial intervention is often helpful. Dosage should be titrated to effect. The recommended dose titration schedule is shown in the table below. Dose titration, final dosage, and wear time should be individualized according to the needs and response of the patient. Patients converting from another formulation of methylphenidate should follow the above titration schedule due to differences in bioavailability of DAYTRANA compared to other products.
The parent or caregiver should be encouraged to use the administration chart included with each carton of DAYTRANA to monitor application and removal time, and method of disposal. It is recommended that parents or caregivers apply and remove the patch for children; responsible adolescents may apply or remove the patch themselves if appropriate.
The area selected should not be oily, damaged, or irritated. Apply patch to the hip area avoiding the waistline, since clothing may cause the patch to rub off. When applying the patch the next morning, place on the opposite hip at a new site if possible. No effects on morphological development were observed in embryo-fetal development studies with oral administration of methylphenidate to pregnant rats and rabbits during organogenesis.
When methylphenidate was administered orally to rats throughout pregnancy and lactation, offspring growth and survival were decreased at maternally toxic doses see Data. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U. Animal reproduction toxicity studies with transdermal methylphenidate have not been performed. Limited published literature, based on breast milk sampling from five mothers, reports that methylphenidate is present in human milk, which resulted in infant doses of 0.
There are no reports of adverse effects on the breastfed infant and no effects on milk production. Long-term neurodevelopmental effects on infants from stimulant exposure are unknown. Monitor breastfeeding infants for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain. Long-term effects of methylphenidate in children have not been well established. Children who are not growing or gaining weight as expected may need to have their treatment interrupted [ see Warnings and Precautions 5.
Rats treated with methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only. Studies with transdermal methylphenidate have not been performed in juvenile animals. The clinical significance of the long-term behavioral effects observed in rats is unknown.
See warning containing drug abuse information [ see Boxed Warning ]. See warning containing drug dependence information [ see Boxed Warning ]. Signs and symptoms of acute methylphenidate overdosage, resulting principally from overstimulation of the CNS and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions may be followed by coma , euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, dryness of mucous membranes, and rhabdomyolysis.
Remove all patches immediately and cleanse the area s to remove any remaining adhesive. The continuing absorption of methylphenidate from the skin, even after removal of the patch, should be considered when treating patients with overdose.
Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia. As with the management of all overdosages, the possibility of multiple drug ingestion should be considered. The physician may wish to consider contacting a poison control center for up-to-date information on the management of overdosage with methylphenidate.
It is a white to off-white powder and is soluble in alcohol, ethyl acetate, and ether. Methylphenidate is practically insoluble in water and petrol ether. Its molecular weight is Its empirical formula is C 14 H 19 NO 2. The structural formula of methylphenidate is:. The methylphenidate is dispersed in acrylic adhesive that is dispersed in a silicone adhesive.
The composition per unit area of all dosage strengths is identical, and the total dose delivered is dependent on the patch size and wear time. The active component of the patch is methylphenidate. The remaining components are pharmacologically inactive. Methylphenidate is a central nervous system CNS stimulant. Methylphenidate is a racemic mixture comprised of the d- and l- enantiomers.
The d- enantiomer is more pharmacologically active than the l- enantiomer. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and increases the release of these monoamines into the extraneuronal space. The amount of methylphenidate absorbed systemically is a function of both wear time and patch size. In patients with ADHD, peak plasma levels of methylphenidate are reached at about 10 hours after single application and 8 hours after repeat patch applications On single dosing of children or adolescents with DAYTRANA, there was a delay of, on average, 2 hours before d -methylphenidate was detectable in the circulation.
On repeat dosing, low concentrations 1. The observed exposures with DAYTRANA could not be explained by drug accumulation predicted from observed single dose pharmacokinetics and there was no evidence that clearance or rate of elimination changed between single and repeat dosing. Neither were they explainable by differences in dosing patterns between treatments, age, race, or gender. This suggests that transdermal absorption of methylphenidate may increase with repeat dosing with DAYTRANA; on average, steady-state is likely to have been achieved by approximately 14 days of dosing.
When applied to inflamed skin, lag time is no greater than 1 hour, T max is 4 hours, and both C max and AUC are approximately 3-fold higher. Median T lag occurs 1 hour earlier, T max occurs 0. Application sites other than the hip can have different absorption characteristics and have not been adequately studied in safety or efficacy studies. Mean plasma concentration-time plots are shown in Figure 1. C max of l -methylphenidate was also proportional to the patch dose.
AUC 0-t of l -methylphenidate was only slightly greater than proportional to patch dose. This may be due to continued distribution of MPH from the skin after patch removal.
Methylphenidate is metabolized primarily by de-esterification to alpha-phenyl-piperidine acetic acid ritalinic acid , which has little or no pharmacologic activity. Transdermal administration of methylphenidate exhibits much less first pass effect than oral administration. In addition, very little, if any, l- methylphenidate is systemically available after oral administration due to first pass metabolism, whereas after transdermal administration of racemic methylphenidate exposure to l- methylphenidate is nearly as high as to d- methylphenidate.
The pharmacokinetics or the pharmacodynamic food effect performance after application of DAYTRANA has not been studied, but because of the transdermal route of administration, no food effect is expected.
Carcinogenicity studies of transdermal methylphenidate have not been performed. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors and the significance of these results to humans is unknown.
Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or in the in vitro mouse lymphoma cell forward mutation assay. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese hamster ovary cells.
Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay. Methylphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an week continuous breeding study.
The patch wear time was 9 hours in all three 3 studies. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. See the chart below for information regarding available strengths.
Do not store patches unpouched. Do not store patches in refrigerators or freezers. Once the sealed tray or outer pouch is opened, use contents within 2 months. Apply the patch immediately upon removal from the individual protective pouch. For transdermal use only. Advise patients, caregivers, and family members of the possibility of painful or prolonged penile erections priapism.
Instruct the patient to seek immediate medical attention in the event of priapism [ see Warnings and Precautions 5. Advise patients of the possibility of a persistent loss of skin pigmentation at, around and distant from the application site. Advise patients to immediately inform their healthcare provider if changes in skin pigmentation occur [ see Warnings and Precautions 5.
The site of application must be alternated daily. The patch should not be applied to the waistline, or where tight clothing may rub it. DAYTRANA should be removed approximately 9 hours after it is applied, although the effects from the patch will last for several more hours.
Patients or caregivers should avoid touching the adhesive side of the patch during application, in order to avoid absorption of methylphenidate. If they do touch the adhesive side of the patch, they should immediately wash their hands after application.
In the event that a patch does not fully adhere to the skin upon application, or is partially or fully detached during wear time, the patch should be discarded according to the directions provided in this label, and a new patch should be applied [ see Dosage and Administration 2.
If a patch is replaced, the total recommended wear time for that day should remain 9 hours, regardless of the number of patches used. If there is an unacceptable duration of appetite loss or insomnia in the evening, taking the patch off earlier may be attempted before decreasing the patch dose.
If any swelling or blistering occurs the patch should not be worn and the patient should be seen by the prescriber. Patients or caregivers should not apply hydrocortisone or other solutions, creams, ointments, or emollients immediately prior to patch application, since the effect on patch adhesion and methylphenidate absorption has not been established. Stimulants may impair the ability of the patient to operate potentially hazardous machinery or vehicles.
Patients should be cautioned accordingly until they are reasonably certain that DAYTRANA does not adversely affect their ability to engage in such activities. Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with DAYTRANA and should counsel them in its appropriate use. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents.
Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
For more information call or visit www. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicine or street drugs. Talk to your healthcare provider before taking this medicine if you have any of these conditions.
Tell your doctor about all of the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines that you take. Keep a list of them to show your doctor and pharmacist.
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